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Introduction to

Health Level Seven (HL7)


International Organization &
Process Orientation

January 2018
HL7 Working Group Meeting
New Orleans, LA January 2018

Calvin Beebe
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Agenda

 HL7 International
➢ What is it
➢ How is it Organized
➢ Vision and Mission
➢ Organizational Chart
➢ Affiliates
➢ Role in enabling interoperability
➢ What’s in a name?

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Agenda
 How do we work?
➢ Consensus Driven
➢ Work Groups
➢ Technical Steering Committee
➢ Steering Divisions
 HL7 International Processes
➢ Meetings
➢ Projects
➢ Ballots
 HL7 Products
 Appendices
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HL7 INTERNATIONAL
WHAT IS IT &
HOW IT IS ORGANIZED?

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What is HL7 International?

 HL7 International is one of several American


National Standards Institute (ANSI)
accredited Standards Developing
Organizations (SDOs) operating in the
healthcare arena.
➢ Most of these SDOs produce standards
(sometimes called specifications or protocols) for a
particular healthcare domain such as pharmacy,
medical devices, imaging or insurance (claims
processing) transactions.
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HL7 International’s Vision

A world in which everyone can


securely access and use the right
health data when and where they
need it.

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HL7 International

 HL7 International is a not-for-profit Standards


Development Organization (SDO)
➢ Headquartered in Ann Arbor, MI
➢ Has an office in Brussels, Belgium
 HL7’s members (providers, vendors, payers,
consultants, government groups and others who
have an interest in the development and
advancement of clinical and administrative
standards for healthcare) develop HL7’s
standards.

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HL7 International’s Mission

HL7 empowers global health data interoperability by


developing standards and enabling their adoption and
implementation.

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HL7 Organizational Chart
Two
HL7 Board of Representatives
Directors
Executive
Advisory
Committee International Council
Council
(BoD Officers)

CEO
Chuck Jaffe MD PhD

COO CTO
Mark McDougall Wayne Kubick

Technical Steering
Operations
Committee (TSC)
AMG
Chair: Austin Kreisler

Steering Division: Other Members


Steering Division: Steering Division:
Steering Division: ArB Co-Chairs:
Foundation & Structure & Technical &
International Domain Experts Anthony Julian &
Technology Semantic Design Support
Representatives Melva Peters & Lorraine Constable
Russ Hamm Austin Kreisler & Mary Kay Sandra Stuart &
Floyd Eisenberg Ad-Hoc: Austin Kreisler
& Paul Knapp McDaniel Andy Stechishin
& Freida Hall

Work Groups

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What is an Affiliate?

 An Affiliate is an independent legal entity that:


➢ Represents its country and country affiliate members at Hl7 International
meetings and within its country/ territory on HL7 matters;
➢ Participates in HL7 International’s standards development and
governance processes;
➢ Promotes the relevance and fitness of the HL7 Protocol Specifications,
HL7 Educational Material and Other HL7 Material in its country/territory;
➢ Distributes, translates and localizes the HL7 Protocol Specifications as
appropriate;
➢ Administers and proctors HL7 Certification tests within its Territory when
suitable and authorized to do so as provided below; and
➢ Promote HL7 standards, educates, informs and supports current and
potential users within the Territory to promote consistent and widespread
usage of the standards.

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35 HL7 International Affiliates / Countries
Norway

Argentina

Russia Romania Philippines New Zealand


Serbia
Australia
And growing
Austria
Singapore
United Kingdom
Brazil
Uruguay
Japan
Canada South Korea

Spain Bosnia and


Herzegovina Italy
China Singapore
Switzerland
The Netherlands

India
Croatia Sweden Slovenia
Taiwan

Hong Kong

Czech Republic Denmark Finland France Germany Greece

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Health Level Seven (HL7)

"Level Seven" refers to the seventh level of the


International Organization for Standardization
(ISO) seven-layer communications model for
Open Systems Interconnection (OSI) - the
application level.
The application level interfaces directly to and
performs common application services for the
application processes.
Although other protocols have largely superseded it,
the OSI model remains valuable as a place to begin
the study of network architecture.

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The OSI Model
HL7
7 Application Logical Connection Application
6 Presentation Logical Connection Presentation
5 Session Logical Connection Session

4 Transport Logical Connection Transport

3 Network Logical Connection Network

2 Data Logical Connection Data

1 Physical Physical Connection


Physical

Application 1 Application 2
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HL7 INTERNATIONAL
HOW DO WE WORK?

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HL7 International
is a Consensus Driven
Standards Development
Organization (SDO)

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Consensus Driven Standards

 Are:
➢ Volunteer-driven
➢ Not a full-time commitment by most
➢ Marked by uneven levels of participation
➢ Participant developers have unequal levels of
understanding
➢ Balloted with required resolution of negative ballots
➢ Consensus standards are intended to meet the
needs of the many and thus are prone to
compromise.

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What is HL7 International?
 Like all ANSI-accredited SDOs, HL7 International adheres
to a strict and well-defined set of operating procedures that
ensures consensus, openness and balance of interest.

 A frequent misconception about HL7 International (and


presumably about the other SDOs) is that it develops
software.
➢ While some small amount of software is developed (e.g., tools), what we
actually develop are standards specifications.
➢ Our most widely used standards specifications enable disparate
healthcare IT applications to exchange keys sets of clinical and
administrative data.

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What is HL7 International?

 Members of HL7 International are known


collectively as the “Working Group”, which is
organized into individual work groups.

 The work groups are directly responsible for the


content of the our products.

 Work groups can also serve as a source for


exploring new areas that need to be covered by
HL7 International’s published standards.

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HL7 International’s Work Groups

 Affiliate Due Diligence


 Anatomic Pathology  FHIR Infrastructure  Policy Advisory
 Anesthesia  Financial Management  Process Improvement
 Application Implementation and  Governance and Operations  Project Services
Design  Health Care Devices  Public Health and Emergency
 Architecture Review Board  Healthcare Standards Integration Response
 Arden Syntax  Imaging Integration  Publishing
 Attachments  Implementable Technology  Regulated Clinical Research
 BRIDG Specifications Information Management (RCRIM)
 Child Health  Infrastructure and Messaging  Security
 Clinical Decision Support  International Council  Services Oriented Architecture
 Clinical Genomics  International Mentoring  Structured Documents
 Clinical Information Modeling  Learning Health Systems  Technical Steering Committee
Initiative  Marketing  Templates
 Clinical Interoperability Council  Mobile Health  Vocabulary
 Clinical Quality Information  Modeling and Methodology
 Clinical Statement  Orders and Observations
 Community Based Collaborative  Organizational Relations
Care  Patient Administration
 Conformance & Guidance for  Patient Care
Implementation/Testing  Pharmacy
 Education
 Electronic Health Record s
 Electronic Services & Tooling
 Emergency Care

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Technical Steering
Committee (TSC) - Mission

 Mission: To provide the technical direction to the


HL7 organization to achieve the vision of
creating the best and most widely used
standards in healthcare.
➢ The TSC oversees and coordinates the technical efforts contributed by
the HL7 participants to ensure that the efforts of the Working Group
(WG) are focused on the overall HL7 mission.
➢ TSC will provide input and operationalize the strategic initiatives.. The
TSC also reviews and provides oversight to projects during the
approval process.
 This allows the TSC to identify gaps and overlaps between projects of the
Working Group and the strategic initiatives.

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Technical Steering
Committee - Structure

 Technical Steering Committee -


➢ 6 elected voting representatives, 4 appointed voting members
➢ TSC-elects their Chair; CTO is ex-officio co-chair
➢ Foundation & Technologies Steering Division
 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD
➢ Structure & Semantic Design Steering Division
 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD
➢ Domain Experts Steering Division
 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD
➢ Technical & Support Services Steering Division
 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD

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HL7 Steering Divisions
Steering Divisions

Domain Experts Foundation and Technology Structure and Semantic Design Technical and Support Services

Anatomic Pathology Application Implementation Arden Syntax Education


Anesthesia
& Design (AID) Clinical Decision Support Electronic Services and Tools
Attachments
Biomedical Research Integrated Conformance and Guidance Clinical Statement Healthcare Standards
Domain Group (BRIDG) For Implementation and Electronic Health Integration
Child Health Testing (CGIT) Record (EHR) International Mentoring
Clinical Genomics
Implementable Technology Financial Management Process Improvement
Clinical Interoperability Council
Clinical Quality Information Specifications (ITS) Imaging Integration Project Services
Community Based Infrastructure and Mobile Health (mHealth) Publishing
Collaborative Care (CBCC) Messaging (InM) Orders & Observations
Emergency Care
Modeling & Methodology Patient Administration
Health Care Devices
Learning Health Systems Security Structured Documents
Patient Care Service Oriented
Public Health Emergency Architecture (SOA)
Response (PHER)
Templates
Pharmacy
Regulated Clinical Research Vocabulary
Information Management (RCRIM)

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HL7 INTERNATIONAL
PROCESS
MEETINGS AND BALLOTS

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HL7 International Meetings

 Working Group Meetings occur three times a year.

 September meeting is designated a “plenary”


meeting.
 Monday AM is a special program dedicated to
business and reporting state of the organization.

 Most (if not all) HL7 International work groups have


face-to-face meetings during a working group
meeting
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HL7 International Meetings

 Agenda usually progress work with time allocated


to:
➢ Version 2
➢ Version 3
➢ CDA
➢ FHIR
➢ Joint meetings with related work groups
 Current ballots normally take priority

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HL7 International Meetings

 Work Groups have defined decision making


processes that specify how they run
meetings, debate and vote on issues
discussed in a meetings.

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HL7 International Meetings

 Work Groups can customize their decision


making processes. However:
➢ PIC guidelines constrains the framework
 HL7 International Process Improvement Committee
(PIC) has default and generic templates for decision
making practices
➢ HL7 International’s By-Laws and Policy and
Procedures take precedence
➢ Default conduct is Robert’s Rules of Order.

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HL7 Products and Projects

 Project Lifecycle relies on the concept of HL7


International Products.
 Examples:
➢ Product Brand
 Messaging, Arden Syntax, CDA, XML, FHIR….

➢ Version
 V2, V3, R1, R2, R3, …

➢ Multiple projects may be required to create viable


‘product’

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HL7 Project Criteria
 Be consistent with HL7 strategic direction
 Include appropriate project documentation - project charter, scope,
resources, timelines, assumptions, constraints, planned
deliverables, etc. per PMO methodology
 Be aligned with market demand
 Be sponsored by stakeholders intending to implement the product
produced by the project
 Define a reasonable balloting strategy to meet market demand
and implementation timelines
 Define how the project will engage with other impacted work
groups
 Follow project approval protocols to ensure appropriate project
socialization and sign-off has taken place
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Ballots

 The end product of a ballot process is a


document.
 The document could stand on its own,
however, most balloted documents are a
part of a published Standards Document
(e.g., HL7 2.6, HL7 3.0, FHIR etc.)

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Ballots

 Documents can be:


➢ Informative
 An Informative Document is the product of a Work Group that is not currently
deemed normative, but nonetheless is intended for general publication. It
explains or supports the structure of the HL7 Protocol Specifications, or
provides detailed information regarding the interpretation or implementation of
an HL7 Protocol Specification. The TSC shall approve the issuance of an
informative document ballot.

➢ Draft Document for Comment Only


 A Work Group, with the concurrence of the TSC, may submit proposed
content or requirements documents, such as a Domain Analysis Model
(DAM), to comment-only review. The intent is to gather input from members
outside of the Work Group on the viability and clarity of the proposed content
or requirements document. The review of proposed content or requirements
documents does not seek a vote, per se, but will capture all comments.

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Ballots
 Standards for Trial Use (STU)
➢ Content is balloted by the general membership as the draft of a
future standard which will, following a pre-specified period of
evaluation and comment (usually 2 years), be expeditiously
incorporated into normative standard.
➢ STU’s require at least two verified implementations that
demonstrate the standard’s use.
➢ Prior to 2016, these were referred to as “Draft” (DSTU’s).
 Normative Standard
➢ Content is balloted by the general membership and is considered
a structural component of the HL7 Standard.
➢ Negative ballots must be resolved.
➢ Normative Standards are typically registered with ANSI.

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Ballots
▪ Ballots normally progress through two or
more cycles of ballots.
▪ Ballot pool is limited to declared interested
members;
▪ Negative votes must be accompanied with a
specific reason justifying the negative vote;
▪ Affirmative w/edit change; Abstention with
comment.
ALL HL7 Balloted Standards are introduced first as a STU
and must show some successful implementations before
being advanced as a Normative Standard.

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Ballots
 Work Groups must resolve negative votes:
➢ Accept the voters comment and recommended solution.

➢ Negotiate with the voter and get them to agree to


withdraw their negative.
➢ Declare the vote non-persuasive.

➢ Voters may appeal to the TSC and Board. They can also
re-vote their same negative vote on the next round of
balloting.
➢ Substantive changes to a ballot (either to fix a negative
or add new material) merit another round of balloting.

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Ballots

 When 75% (for normative documents) of


the responses are registered as
affirmatives…and hopefully all negatives
withdrawn, a document is ready for
publication as an HL7 International
Standard.

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HL7 PRODUCTS

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History of HL7
(Through 2012)
Version 1.0 Implementation Version 2.2 Version 2.2
Published Support Guide Published ANSI Version 2.3.1
published Published CDA 1.0
and ANSI

1987 88 89 90 91 92 93 94 95 96 97 98 99 2000 01 02 03 04

Version 2.0 Arden


Charter member of Syntax
Published 2.4 2.5
ANSI HISPP 2.0
First Meeting
Hospital Version 3.0
Version 2.3
University of PA Version 2.1 1st published
Published
Published and ANSI
CCOW

2005 06 07 08 09 10 11 12 13 14 15 16 17

Reorganizes FHIR FHIR


V2.6 FHIR
First work on SOA Hires CEO & CTO & V2.7 V2.7.1
(Services) w/HSSP starts work on SAIF
Pub- DSTU DSTU DSTU
lished 1 2 3
CDA 2.0
V3 20xx Normative Editions
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HL7 International Products

▪ HL7 International has a number of major


product lines:
➢ Version 2.x
➢ Version 3 Reference Information Based Products
• Version 3 Messaging
• Version 3 Clinical Document Architecture (CDA)
• CDA Implementation Specifications or IGs (e.g., CCD)
Version 3 Services

• Gello
• Attachments
• Structured Product Labeling
– EHR-S & PHR-S Set of Standards
– FHIR (Fast Health Interoperability Resources)
– Arden Syntax

A project to create Product-Line Management and coordinate common elements and


better define “backward-break” issues is now being formulated in the Technical Steering
Committee.
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HL7 International Diversifies
 HL7 International started with and is traditionally thought of as
“messaging”. For most of its life, however, HL7 International has also
produced more than messaging standards.
➢ Electronic Data Exchange in Healthcare Environments (i.e. “messaging”)
 Version 2 & Version 3

➢ Arden Syntax
➢ GELLO
➢ Visual / Context Integration (CCOW)
➢ Version 2.x XML (XML encoding of HL7 International messages)
➢ Clinical Document Architecture (CDA)
 Clinical Context Document Implementation Guide (CCD)
➢ Electronic Health Record System (EHR-S) Functional Model
➢ Personal Health Record System (PHR-S) Functional Model
➢ Services (i.e., Services as related to a Services Oriented Architecture)

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HL7 Subject Domains
 ADT  Mobile Computing
 Order entry  Adverse event reporting
 Result reporting  Automated waveforms
 Clinical Guidelines  Medical transcriptions
 Clinical Observations  Referrals
 Scheduling  Consultations
 Patient care  Clinical trials
 Immunizations  Nursing care plans
 Discharge summaries  Data Warehousing
… And Growing …

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HL7 Subject Domains
 XML  Personnel Management
 Terminology/Vocabulary/  Arden Syntax
Ontology  Component Based
 Certification Messaging (i.e., Java)
 Conformance  Visual/Context Integration
 Security transactions  Government Projects
 Claims attachment  Master Patient Index
 Accountability, Quality,  SOA
Assurance  Image Management
 Blood Bank
… And Growing …

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HL7 INTERNATIONAL
VERSION 2.X

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HL7 International Version 2.x

 First widely used version 2.1 published in 1991


 Used in 90%+ provider organizations in the US and widely supported
by vendors.
 Generally requires bi-lateral negotiations between communicating
parties.
 Backwards-fitted (imperfectly to HL7 International Reference
Information Model (RIM))
 Not well normalized.
➢ Segments & Data Elements moved to a single location (Chapter 2) only in 2.5 in
2003.
 Makes no formal attempt to define process
 Most implementations are a mix of versions ranging from 2.1 to 2.3
(even though current version is 2.7)

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Version 2.7 Chapters*
1. Introduction 12. Patient Care
2. Control / Data Types / 13. Clinical Laboratory Automation
Conformance & Code Tables
14. Application Management
3. Patient Administration
15. Personnel Management
4. Orders
16. Non-US eClaims (new to 2.6)
5. Queries
17. Materials Mgmt. (new to 2.6)
6. Financial Management
7. Observations
Appendices:
8. Master Files A. Data Definition Tables
9. Medical Records / Information Mgmt B. Lower Layer Protocol
C. BNF Definitions
10. Scheduling D. Glossary
11. Patient Referral E. Index

2.7 is available on the HL7 “Standards” section of the HL7 web site. CDs are also available.

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HL7 INTERNATIONAL
VERSION 3

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HL7 Version 3

 A suite of specifications based on HL7’s


Reference Information Model (RIM)
 Represented a new approach to clinical
information exchange based on a model
driven methodology

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V3 RIM

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HL7 International Version
3
First approved for
publication and pro-motion
to ANSI as an HL7
Standard in September,
2004.
Current Version: 2015
Normative Edition

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Clinical
Document
Architecture

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HL7’s CDA vs. C-CDA

C-CDA defines a set of CDA documents!


The HL7 Consolidated CDA is an implementation
guide which specifies a library of templates and proscribes
their use for a set of specific document types.

CDA the schema for those documents!


The HL7 Clinical Document Architecture (CDA) is a
document markup standard that specifies the structure and
semantics of "clinical documents" for the purpose of
exchange.

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Consolidated CDA (C-CDA 2.1)
Continuity of Care Document History and Physical
ONC - CEHRT Discharge Summary
C HITSP - C32, C80, C83 Consultation Notes
C IHE – PCC Diagnostic Imaging Rpt
D HL7 – CCD Procedure Note
HL7 – CDA
Operative Note
Progress Note
Unstructured Documents
C-CDA HL7 Health Story Implementation Guides
Care Plan
Referral Note
Transfer Summary
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Fast Healthcare Interoperability
Resources (FHIR)

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What the Market Wants
 Faster implementations
 Conformance & Conformability testing
 Computable Semantic Interoperability
 Better Quality, Methodology & Tools
 Confidentiality/Security
 Harmonization with other standards
 Support of the latest communication
technologies

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30 second “Intro to FHIR”
 Pronounced “FIRE”
 Arose from the “Fresh Look Task Force” in 2012
 As significant as the leap from v2 to v3;
➢ Still leverage v3 infrastructure & knowledge
➢ But focus more on ease of implementation
 RESTful enabled and based on resources but also supports
document, messaging & services paradigms;
 All data is contained in a set of 100 resource definitions (for all
of healthcare)
 Employs the 80-20 rule: Resources contain the elements 80%
of systems will actually use;
 Everything else is handled by controlled extensions.

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30 Second “Intro to FHIR”

 There was strong support from the US


ONC’s Standards Advisory Panel for FHIR.
➢ Led by Dr. John Halamka
 ONC commissioned the creation of the
JASON report (suggested reading).
➢ Jason Report (Final)
 Recent HHS and ONC announcements
encourage use of FHIR API for EHRs.

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Project Argonaut

▪ This is not a HL7 project – though HL7 has


supported it and it is tightly connected to the FHIR
community.
▪ The approximately 70 Argonaut participants have
pooled resources with the intent to focus on
verifying FHIR solutions and producing FHIR
implementation guides.
▪ Arose from the JASON Task Force, to enable API-
based access to data via patient/provider portals
and data exchange.
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THE MOST HELPFUL SINGLE
PIECE OF INFORMATION?

http://www.hl7.org

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Other Useful Links

 HL7 Glossary
 HL7 Work Groups
 HL7 Governance and Operations Manual

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QUESTIONS?

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THANK YOU

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ADDITIONAL SLIDES

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What is HL7 International?

 HL7 International’s domain is clinical and


administrative data.
 Many of our Standards are also ISO TC-215
Standards.
 ISO TC-215 both adopts specific HL7
International Standards and also works with
HL7 International to jointly develop standards.
 HL7 also collaborates with many other SDOs,
such as through the Joint Initiative Council.
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Enabling Interoperability
 Interoperability beyond a single point to point
interface requires:
➢ A profile that includes all of the related Standards
Development Organizations (SDOs’) elements (e.g.,
terminologies), and other directed references within the
primary SDO product (e.g., state names & abbreviations).
➢ A resolution of all pre-coordinated decisions to remove all
optionality;
➢ Full specification from Layers 1-7 (e.g., FHIR) (not just
Level 7)
➢ The publication of an implementation guide that is used by
all communicating parties.
➢ A published governance and update process that supports
needed fixes and related updates.

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Examples of Influencers &
Drivers
 Governments (US ONC, Canada Health Infoway,
Australia’s NEHTA, UK’s NHS CfH, …)
 American National Standards Institute (ANSI—and other
complementary national bodies)
 Vendors
 HL7 International Affiliates
 Clinical users & Consultants
 Healthcare Ontology/Terminology SDOs (e.g., IHTSDO
(SNOMED), Regenstrief (LOINC), WHO, (ICD), etc.)
 Other International Standards Organization
(ISO, DICOM, GS/1, CEN TC 251, etc.)
 Other US Healthcare related SDOs
(e.g., X12N, NCPDP, etc.)

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U.S. Health Messaging Standards
Development Efforts

HL7 International
(Health Level 7)

ACR/NEMA (DICOM)
(American College of Radiologists / National
Electrical Manufacturers Association)
(Digital Image Communications)

X12 (X12N)
ASTM (E31)
ASTM International
(was American Society of Testing Materials)

IEEE
(Institute of Electrical and Electronic Engineers)

NCPDP
(National Council of Prescription Drug
Producers)

ADA
(American Dental Association)

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HL7—Country and International
Standards

TC 215

Other Countries /
HL7 Affiliates
TC 251

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What is the Origination
of the name HL7?

The application level addresses definition of


the data to be exchanged, the timing of the
interchange, and the communication of
certain errors to the application. The seventh
level supports such functions as security
checks, participant identification, availability
checks, exchange mechanism negotiations
and, most importantly, data exchange
structuring.

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